FDA.reportPublic FDA data

KLARITY MEDICAL

Primary DI
00840510401337
Brand
KLARITY MEDICAL
Company
Klarity Medical Products, LLC
Model
R7641-25NLB5
Device description
Klarity Vacuum Bag 123.5cm x 80cm, 25 liter fill, with two Indexing Bars and Civco-style valve
Published
2026-06-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132124000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132124000KLARITY VACUUM BAG, KLARITY MOLD CUSHIONKlarity Medical Products, LLC2013-11-01IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840510401337PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840510401337008405104013378405104013370840510401337

GMDN Terms#

Term, Definition table
TermDefinition
Vacuum-mould patient positioning systemAn assembly of devices designed to apply a vacuum to a cushion or bag filled with foam-like material that is placed under, on, or around a patients body parts. A vacuum is applied to the contents of the cushion forming a patient specific (custom-made) mould. The moulds can be whole body or selected body parts and help ensure adequate positioning and immobilization of the patient during diagnostic imaging and/or radiation therapy procedures facilitating reproducible positioning for serial procedures. This system typically includes reusable foam-filled bags, cushions, a vacuum unit, hardware, seals, and interfaces used to connect the mould to another patient positioning system (PPS).

Regulatory Flags#

DUNS number
034824691
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840510401283KLARITY MEDICALR616-HT22026-06-01
00840510401290KLARITY MEDICALR624-SCF1-62026-06-01
00840510401306KLARITY MEDICALR624-SCF1-82026-06-01
00840510401313KLARITY MEDICALRE-7B2026-06-01
00840510401276KLARITY MEDICALR550-SC2026-05-29
00817355024847KLARITY MEDICALR-4000F2020-08-28
00840510401245KLARITY MEDICALR-1600E2026-05-14
00840510401252KLARITY MEDICALR-2436E2026-05-14
00840510401269KLARITY MEDICALR-3200E2026-05-14
00840510401214KLARITY MEDICALKRA3-45602026-05-07
00840510401221KLARITY MEDICALKRA3-52332026-05-07
00840510401238KLARITY MEDICALR7627-20C2026-05-07
00840510401191KLARITY MEDICALR550-HS32026-05-05
00840510401207KLARITY MEDICALR7301-10C2026-05-05
00840510401184KLARITY MEDICALRB-PRT3-2410F2026-04-30
00840510401177KLARITY MEDICALR7702-85C2026-04-29
00840510400293KLARITY MEDICALR7703-117NHC2025-10-15
00840510401160KLARITY MEDICALGR7661-A20C2026-04-17
00817355028524KLARITY MEDICALR624-SCF1-5B2026-02-12
00840510400231KLARITY MEDICALRNE-104CLP2025-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840510401283KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401290KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401306KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401313KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401276KLARITY MEDICALKlarity Medical Products, LLCIYE2026-05-29
08057014731224LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
08057014731231LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
08720168162595Mask DSPS®-PROSH set/5MACROMEDICS B.V.IYE2026-04-23
08720168162564DSPS-Prominent® Cradle-IIMACROMEDICS B.V.IYE2026-04-22
08720168162571Mask DSPS®-PROSHVRL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162618Mask DSPS®-PROSHL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162649Mask DSPS®-PROSHVR set/5MACROMEDICS B.V.IYE2026-04-22
08720168162748Mask DSPS®-PROH, set/5MACROMEDICS B.V.IYE2026-04-22
08720168162755Mask DSPS®-PRO, set/5MACROMEDICS B.V.IYE2026-04-22
08720168162779DSPS-Prominent® Cradle-IIIMACROMEDICS B.V.IYE2026-04-22
08720168162786DSPS-Prominent® Cradle-IVMACROMEDICS B.V.IYE2026-04-22
08720168162793DSPS-Prominent® Cradle-VIMACROMEDICS B.V.IYE2026-04-22
08720168162854Mask DSPS®-PROSCVRL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162861Mask DSPS®-PROSC set/5MACROMEDICS B.V.IYE2026-04-22
08720168162878Mask DSPS®-PROSCVR set/5MACROMEDICS B.V.IYE2026-04-22
08720168162885Mask DSPS®-PROSCL set/5MACROMEDICS B.V.IYE2026-04-22
08720168163325DSPS-Prominent® Cradle-VIIMACROMEDICS B.V.IYE2026-04-22
08720168163356DSPS-Prominent® SH profile set/2MACROMEDICS B.V.IYE2026-04-22
08720168163387DSPS PRO Mask Shim Set HNSMACROMEDICS B.V.IYE2026-04-22
08720168163394DSPS PRO Mask Shim Set HOMACROMEDICS B.V.IYE2026-04-22
08720168160140DSPS-Prominent® baseplate MACROMEDICS B.V.IYE2026-04-21
08720168162557DSPS-Prominent® Cradle-IMACROMEDICS B.V.IYE2026-04-21
08720168162908Handgrips HNS, set/2MACROMEDICS B.V.IYE2026-04-21
EPTWS070031Q5200VERIQAPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-17
EPTWS0700300PQASoftPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-15